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Regulatory Affairs – the new IRIS platform for scientific advice

By Jürgen Reiher

21 December, 2020


Regulatory Affairs – the new IRIS platform for scientific advice

Jürgen Reiher



What is the IRIS Platform, and Why Is It Vital For Human Medicine Developers?

The European Medicines Agency (EMA) has announced that developers of human medicine who wish to apply for scientific advice must be registered to its IRIS platform, effective from October 19th 2020.

To some this may initially appear to create new and unnecessary compliance hurdles for ambitious developers.

However, far from creating barriers this move is part of an exciting movement to improve the flow of information and ensure medicine is developed safely and effectively.

What is IRIS?

The EMA’s IRIS Regulatory & Scientific Information Management Platform is a centralised space for the sharing of information related to medical advice – from filing requests to delivering documents concerning a given scientific advice procedure.

Previously, it had been used only for orphan drug designation procedures, but this expansion to include developers of human and veterinary medicine will see it become a vital part of the development process.

In order to fast-track adoption, the EMA is also offering free training sessions to help developers get up to scratch on the platform.

Why is it beneficial?

The chief reason for mandating the use of IRIS is to ensure communication between parties is fluid and in-line with the current technological capacity.

IRIS will help harmonize previously existing processes and make the sharing of high-quality information and data both easier and more frequent.

It’s also important to note that this will help streamline processes for developers and save a huge amount of time – all in all, a clear victory for progress.

How will IRIS affect you?

One downside of IRIS is the imposition of requirements: having to undertake training or jump through the hoops of registering with the EMA might prove frustrating and costly.

Four clients of Assion, however, IRIS is only positive: we are already registered to IRIS and deeply familiar with its system. This means our clients need not worry – they are already complying the EMA’s stated advice, and will see no friction in their development processes because of it.

If you would like support in becoming compliant and ensuring that you are following the correct processes, contact us today on

Jürgen Reiher


Jürgen leads all our strategic planning and commercial implementation. Prior to joining Assion, throughout his career in pharma and as a consultant, he’s led the development of multiple strategic plans, complex market access dossiers, KOL engagements and management consulting projects.

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